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Journal of Regulatory Compliance

Improving the Biosimilar and Generic Drug Approval Process

Andrew Thompson Senior Editor Loyola University Chicago School of Law, JD 2023 As discussed previously here and here, patent evergreening and patent thickets are key drivers of prescription drug prices that also operate as a barrier to entry which blocks generic manufacturers from placing lower-cost alternatives on the market. This post will examine how newly …
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New Incentives from the DOJ to Urge Companies to Self-Report Crimes

In an action meant to incentive companies to self-report their wrongdoings, the Justice Department (DOJ), has announced big changes to its Corporate Enforcement Policy (CEP). The Department of Justice has long been fighting against corporate criminality in its pursuit to maintain the integrity of the financial market. On January 17, Assistant Attorney General Kenneth A. Polite, Jr., announced revisions to the Criminal Division’s Corporate Enforcement Policy. Some of the revisions include up to a 75 percent reduction in fines for companies that voluntarily report their wrongdoings and fully cooperate with investigations and up to a 50 percent reduction for companies that fully cooperate with investigations even if they do not voluntarily disclose the crime. These incentives further soften the aggressive stance that the Biden administration originally took against Corporate America in 2021.

What Does The “ENABLERS Act” Mean for Attorney Regulation?

The Financial Crimes Enforcement Network (FinCEN) is a bureau of the U.S. Department of Treasury committed to safeguarding the financial system by detecting and preventing money laundering, the financing of terrorism, and other illicit activity since the 1970s. The Bank Secrecy Act (BSA) expanded the definition of “financial institution.” The ENABLERS Act (Act) is the latest proposed amendment that seeks to expand the provisions of the BSA to several different professions, such as lawyers, trust companies, investment advisors, accountants, public relations firms, and art dealers, amongst others. Should this amendment pass, it will be the most significant money laundering reform yet. It will expand its reach by requiring these financial service providers to adopt anti-money laundering safeguards to close the loophole in the U.S. anti-money laundering system. The safeguard will require these professionals to help prevent and report cases of money laundering by implementing due diligence rules in their practice to ensure that the money entering the system is not “dirty.” This is currently not required of lawyers or any of these other professions.

The Downfall of Twitter: Layoffs Rocking Big Tech

Over the last several weeks we have seen mass layoffs across big tech, including Salesforce, Twitter, and Meta. This comes after big tech peaked during the COVID-19 pandemic when it was essential to the nation in keeping us virtually connected. During the lock down tech giants’ profits soared as consumers upgraded devices, maximized increased storage, and were forced to get creative in communicating in the workspace. However, inflation, rising interest rates, and digital spending are driving big tech companies to implement large-scale layoffs as the economy prepares to take a downturn. While Meta CEO, Mark Zuckerberg, described the announcement as one of his hardest decisions, Twitter CEO, Elon Musk, has taken a different approach, causing continuous chaos that has led to compliance risks.

Google Becomes the First to Agree to Compliance Monitoring by the DOJ

In an action to keep company executives in check, the Justice Department (DOJ), created a policy where executives and compliance chiefs sign and personally attest to the effectiveness of their compliance programs. The individuals would therefore be held personally liable for their roles in the company’s wrongdoing. The DOJ and Google had a pending dispute, which was due to Google’s non-compliance with assisting authorities in an investigation. The DOJ and Google reached an agreement, with a stipulation attached, resolving the dispute over Google’s loss of data responsive to a 2016 search warrant. In the stipulation, Google has said that it has spent over 90 million dollars on additional systems and resources to improve its compliance programs, including an agreement to allow an Independent Compliance Professional to serve as a third party to monitor that Google is fulfilling its compliance legal obligations. This policy, as already seen in the settlement with Google, is forcing compliance to become a top-tier concern for big companies or face serious consequences.

Return of the Union: How Workers are Organizing and Corporations Are Trying to Stop Them

In the last few years, especially after the start of the COVID-19 pandemic, there has been a noticeable growth in US labor organizing. Workers all over the country, from both large corporations and small companies, have gone on strikes and began forming labor unions in an effort to get better wages, working conditions, and benefits. Most recently, employees at large rail unions rejected a tentative deal to avert a walkout in September 2022 after it failed to adequately address their concerns. This is the latest, but certainly not the only, instance of workers demonstrating their increased bargaining power. We have also seen increased unionization movements by corporate employees at corporations like Amazon, Google, and Starbucks. However, as more corporate employees attempt to unionize, corporations have begun to push back, and the National Labor Relations Board (NLRB) has stepped in to put a stop to blatant anti-unionization efforts.

Grocery Stores Merging: Will the FTC Allow the Kroger-Albertsons Deal to Proceed?

The current largest supermarket powerhouse Kroger announced on October 14 their intent to merge with Albertsons Companies, Inc., another huge supermarket retailer in the industry. Kroger owns many well-known stores such as Mariano’s, Ralphs, and of course it’s’ namesake, Kroger. Albertsons Companies owns the Chicago-land staple Jewel Osco and Safeway, among other supermarkets as well. The companies have executed an agreement for Kroger to acquire Albertsons for $24.6 billion. The merger comes in response to the rise of grocery shopping being done at “big box” stores like Walmart and Target, on top of rising food and produce prices from inflation and supply chain issues. However, the merger is facing a lot of backlash, and many are questioning whether it will even be able to pass regulatory procedures. If the deal is approved, it is questionable whether the merger between the two grocery giants will trickle down benefits to consumers.

The Clock Continues to Tick for SEC Climate Proposal

Juhi Desai Associate Editor Loyola University Chicago School of Law, JD 2024 In March 2022, the U.S. Securities and Exchange Commission (SEC) released a 490-page proposal encouraging organizations to adopt climate-focused regulations. The policies could include climate disclosure requirements and an expense report detailing the effect climate change has on businesses. However, shortly after the …
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Twitter Whistleblower Exposes FTC’s Ineffective Efforts to Protect User Data

Danielle McNamara Senior Editor Loyola University Chicago School of Law, JD 2023 In July 2022, former Twitter board member Peiter Zatko filed a complaint against Twitter, alleging that  the social media platform failed to develop a security system consistent with the Federal Trade Commission’s (FTC) requirement to implement a comprehensive information-security program, established in 2011. …
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Consumers are Suing Dozens of Companies for Sharing Tracking Data

A privacy class action that first exploded in September of this year highlights consumers suing a handful of companies for violating the federal Video Privacy Protection Act. The multitude of class actions hold the Meta Platforms Inc’s Pixel tracking tool accountable for the tracking of consumer data from online platforms. News outlets, sports organizations, and streaming services are all facing lawsuits related the alleged complaints.